OTE MPS 045 Multi-purpose Lens Care Solution— 510(k) K210051
Substantially EquivalentOte North America, LLC
FDA 510(k) clearance K210051 for OTE MPS 045 Multi-purpose Lens Care Solution, Substantially Equivalent on 2021-05-26. Applicant: Ote North America, LLC.
Clearance details
- Applicant
- Ote North America, LLC
- Product code
- Code LPN
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Inwood, NY, US
Adverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.